Ketorolac Tromethamine
Ketorolac Tromethamine Injection, USP
Approved
Approval ID
4bdf1611-af60-4f0b-9bc7-57bc117b0dc6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2024
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ketorolac tromethamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-4635
Application NumberANDA204216
Product Classification
M
Marketing Category
C73584
G
Generic Name
ketorolac tromethamine
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateJune 20, 2019
FDA Product Classification
INGREDIENTS (6)
alcoholInactive
Code: 3K9958V90M
Classification: IACT
KETOROLAC TROMETHAMINEActive
Quantity: 30 mg in 1 mL
Code: 4EVE5946BQ
Classification: ACTIB
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT